Manufacturing

High Containment Operations

Our High Containment Operations (HCO) handle highly potent compounds through a closed manufacturing system with a capability of handling substances down to an occupational exposure level (OEL) of 0.1 µg/m3 or less. We currently have multiple dedicated processing suites and supporting infrastructure, along with a dedicated packing room, remote data acquisition system & documentation room. For each chemical moiety introduced, aggressive assessment studies are performed to ensure there is no contamination.

Our analytical testing labs are furnished with appropriate equipment such as safety workbenches for sample preparations, containment hoods and isolators for testing samples, and separation from the normal lab areas and with limited access. Eridanus complies with all applicable laws with respect to the environment, occupational health and safety, public health & safety, waste disposal, and holds all current and applicable governmental licenses, approvals, permits & authorizations.

Eridanus currently references the SafeBridge® categorization scheme and works with SafeBridge® Category 1-4 compounds. The SafeBridge “Occupational Health Toxicity/Potency Categorization and Handling Practices” system (copyright SafeBridge Consultants, Inc., Fifth Revision – January 2002, pp.12), is a four-category system to characterize compound potency.

Dosage Form Capabilities

Located in Irvine California, Eridanus cutting-edge cGMP manufacturing capabilities include facilities from pilot plant and clinical scale production, through to commercial batch manufacturing. The manufacturing facility resides within a sprinkler-equipped, concrete building that encompasses approximately 37,0000 sq. feet, and is capable of producing over 2 billion oral doses per year, with a batch size capacity of 0.5 kg – 600 kg. The clean rooms (Class 100,000/ISO Class 8) have a minimum of 12-foot ceilings. The manufacturing room environments are designed to maintain a temperature of 18-24°C. The air-handling system provides a minimum of 20 changes of filtered air per hour. The air quality (air particulate & microbial levels) is monitored periodically according to Stason SOP.
Eridanus also operates a dedicated High Containment facility, which is segregated from our Non-High Containment operations, and consists of multiple processing suites, a dedicated packaging room, a documentation room, and field support offices. The air handling system provides a minimum of 40 changes of filtered air per hour.

Clinical Supply & Commercial Pharmaceutical Manufacturing

Eridanus works with virtual start-up companies/inventors, through to mid-size, and top-20 pharma companies. We’re able to enter the development & manufacturing arena at any stage, providing services through to your commercial expectations, and producing up to 2 billion oral doses per year. For semi-solid dose formulations, we typically handle bench-top through phase 2 clinical trial production.

Bench-Top (0.5 – 1 kg)

Pilot (3-5 Kg)

Commercial (50-600 kg)

QC Testing & Stability Monitoring for Commercial Manufacturing

The future of CMC regulatory review is based on Quality-by-Design (QbD), and the CMC Regulatory Decision is based on CMC Quality & Performance. Eridanus has quality control systems, which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Eridanus offers quality control (QC) testing for Active Pharmaceutical Ingredients (API’s), pharmaceutical intermediates, excipients, and finished products.

Stability storage conditions meet ICH guidelines. Each cGMP environmental chamber operates independently, with separate temperature controls, and monitored continuously through a validated environmental monitoring system. All storage chambers are supported by full generator back-up, in case of power failure.

About Us

Established in 1994, Eridanus Healthcare, Inc. started as a generic drug manufacturer, and today—while venturing into IND development—continues to manufacture and market these products through our global network of distributors.

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